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PharmaCyte Biotech Receives ‘Notice of Allowance’ for Patent Protection of the Melligen Cells to Treat Diabetes
"A Notice of Allowance signifies that the applicant is entitled to receive patent protection of 20 years under the law. The Melligen cells were developed by Prof. Ann Simpson and her colleagues at the University of Technology Sydney (UTS). PharmaCyte has a license agreement with UTS that provides PharmaCyte with the exclusive worldwide right to use Melligen cells for the treatment of diabetes."
All I see is PMCB doing all the right things... Thanks KW...
http://ih.advfn.com/p.php?pid=nmona&article=71454446&symbol=PMCB
Great post... I agree KW delivers.
Thanks Pete. It was a great day...
Very true. Yeah, good idea to keep an eye on Cell in a Box. It really may the "magic bullet" that Dr Lohr said...
http://www.marketwatch.com/story/nuvilex-incs-cell-in-a-box-treatment-called-magic-bullets-of-21st-century-by-world-renowned-oncologist-2014-05-05
GLTU
Thanks...
Thank you so much! I like to manage by facts and seeing it myself helps. :). Really appreciate it...
Hey bye, do you have a link with the updates? I think yahoo is not updated properly. Feltz should be showing a 3/31 date and it's showing 12/31.
Thanks
Good news and so is our appointment today... Love this statement from the PR...
"Mr. Waggoner has built a very solid organization, and I look forward to making contributions with pace and rigor to advance our product pipeline towards commercialization.”
Dr. Sanjay Batra
I agree. We knew this was coming when we heard last week's news. Still good to get the official announcement.
"That is the kind of leader to invest in." Thank you Mr. Waggoner. Hope you feel the appreciation of all of us longs... Let's get that "magic bullet" doin' its thing!
Yep, bull... That's why it's so important for us as investors to stay the course as well. They believe in CiaB and are working hard with some of the best PC doctors in the world to get this to patients... I support the team's efforts 100%... Patience is virtue... I await the day we hear how many patients we have helped with PC... That will be the real game changer... Or maybe even a buy-out before that announcement... Nice... GMP!
GLTU
I like the lag. To me it means real interest is reacting vs flippers...
Now, we engage the FDA so we can start affecting some lives! Yay! Good to see you bull...
Thank you...
If they are selling into paid news it is to fund trials and other costs of doing business. It is expected for an R&D biotech.
However, there has been a lot of short action over the last few days since the Thai govt approval, 43-57%...
Most likely traders are the majority of this activity... Their intents are not to help the company move forward.
This is day traders not likely naked shorts btw. Naked short % too low...
http://otcshortreport.com/index.php?index=PMCB&action=view
Same people who bail on a lot of things. That would not be me or any Longs I know...
Good, I missed the time it ran to $11... :)
Is the chart looking good?
Thanks Pete. Hope all is well. :)
$PMCB
Well, since I am here tonight, I will give you my take... Dr. Von Hoff
Leader in Pancreatic Cancer and he carries a torch for a cure.
Lots and lots of connections, including the Mayo Clinic and Celgene.
On the SAB of many biotechs yet he contacted us 2 years ago and is still taking us into trials for two different treatments.
Because of his interest we are conducting trials is the U.S. As well as abroad.
And we have ODD in the U.S. thanks in large part to TD2 and Von Hoff getting involved.
He has seen other treatments to FDA approval and has worked on the Oncology Board of the FDA.
He and his team have redesigned our 2b trial to work in tandem with the Gold standard, CELG, in lieu of going head to head.
I see a lot of very encouraging signs...
:)
That is a loaded question. I think you would benefit by doing some DD. This technology could additionally cure diabetes. Just hope KW is busy working out all the details to your question.
I will tell you, however, there are lots who trade this and a whole lot who are actually holding too. I have been here over two years. Many Longs believe all or some licenses will be bought out....
I think many have no clue as to what is material and what is not. To say that the Thai Government approving the facility, which is the first milestone leading to production, is either naivety or an out right attempt to deceive.
The most recent PR is one of the most material developments to date...
http://pharmacyte.com/pharmacyte-biotechs-encapsulation-facility-for-pancreatic-cancer-therapy-deemed-suitable-by-thai-fda/
He is also human. His father died of Pacreatic Cancer. Motivation drives each of us. I think it is more than just the money that motivates him here. Watching someone you love die of PC is very hard to forget. I am sure he would like to never see that happen again if he has anything to say about it....
NO DOUBT!
I expect to see the next item on the list very soon.... cGMP....
Believe it or not, it is coming...
Who's lying? Certainly not KW. First 2 milestones accomplished...
"Waggoner highlighted the 2016 milestones that PharmaCyte’s shareholders and investment community can look forward to this year:
- Pharmacyte CEO will attend the 2016 JP Morgan Healthcare conference in San Francisco to meet with pharmaceutical companies and potential institutional investors.
- The manufacturing facility in Bangkok, Thailand, where the live cells that convert the cancer prodrug ifosfamide into its cancer-killing form will be encapsulated, will receive a factory license from the Thai government enabling production of the encapsulated cells for PharmaCyte to use in its clinical trials.
- The Austrianova manufacturing facility will become fully compliant with current Good Manufacturing Practices (cGMP) standards.
- An Investigational New Drug Application (IND) will be filed with the FDA following a pre-IND meeting with the FDA.
- Appropriate arrangements will be made with cancer centers in the United States to begin PharmaCyte’s pancreatic cancer trial that will address the critical unmet medical need that exists when a patient’s non-metastatic, pancreatic cancer no longer benefits from receiving the “gold standard” treatment – the combination of gemcitabine and Abraxane®.
- Pharmacyte clinical trial in pancreatic cancer will get underway with Translational Drug Development (TD2) coordinating the trial globally and conducting it in the United States. Clinical Network Services (CNS) will conduct the trial in Europe and Australia in alliance with TD2.
- After the pancreatic cancer clinical trial has been in process for approximately six months, there will be an evaluation of PharmaCyte’s pancreatic cancer treatment on the patients enrolled in the trial with the interim results being reported to the public.
- Additional preclinical studies to determine if PharmaCyte’s pancreatic cancer treatment can slow down the production and accumulation of malignant ascites fluid will take place in 2016. If successful, plans to conduct a clinical trial in ascites will be undertaken by PharmaCyte with the goal of having TD2 begin the clinical trial by year end or early 2017.
- Numerous preclinical studies will be conducted concurrently and in parallel by members of PharmaCyte’s international Diabetes Consortium to condense the time it will take for PharmaCyte to enter into a clinical trial that will test the ability of the Melligen insulin-producing cells encapsulated using the Cell-in-a-Box® technology to treat Type 1 diabetes and insulin-dependent Type 2 diabetes, with the goal of reaching the clinic in 2017.
- Pharmacyte will fill its open Board of Directors positions as appropriate.
- Pharmacyte will conduct periodic shareholder calls, rather than communicating through shareholder updates, with the CEO responding to questions during the calls.
- Pharmacyte will hold an annual shareholder meeting."
http://pharmacyte.com/pharmacyte-biotech-outlines-2016-milestones-as-its-pancreatic-cancer-treatment-moves-into-a-clinical-trial/
Roger that!
The Exciting Story of Pharmacyte Biotech Inc (OTCMKTS:PMCB) Continues
By Frank Synder - April 11, 2016
Pharmacyte Biotech Inc (OTCMKTS:PMCB) closed at an intra-day high on breaking news that its encapsulation facility for pancreatic cancer therapy was deemed suitable by the FDA. This is a very bullish development. The stock has climbed past its highs set in mid-March of $0.074 and current trading at $0.077. It has developed a higher high and poised for more gains from current levels and should easily climb higher from current levels.
The encapsulation facility in Thailand that will be used to encapsulate the live cells used for PharmaCyte’s pancreatic cancer therapy has recently been inspected by the Food and Drug Administration of Thailand. Thai FDA stated through a report that, “The facility is built according to the pre-approved floor plan and is now deemed suitable for the manufacture of pharmaceutical products.”
The Chief Executive Officer stated, “We are very pleased that our partner, Austrianova, has received a positive opinion from the Thai FDA for Austrianova’s live-cell encapsulation facility. This is an important milestone in the development of PharmaCyte’s treatment for pancreatic cancer and a pre-requisite for our upcoming pancreatic cancer clinical trial.”
On April 6th PMCB announced it has changed its clinical trial design. This means that the actual date for the clinical trial is unknown at this point. While the new trial design offers PMCB a much better shot at success with FDA and EMA approval, it has also been an exercise in patience for the company’s leadership and its shareholders.
PMCB just released its financial information with the SEC according to a recent filing. PMCB is set to launch a new clinical trial sometime in 2016 for pancreatic cancer patients. There is a huge unmet medical need and people will welcome a solution that could potentially increase the lifespan for late stage pancreatic patients. If the clinical trial is successful, PMCB will be gaining more than just 50% to investors and likely cause the company to increase in value significantly and potentially be acquired by a larger pharmaceutical company.
Any positive results would move PMCB into the spotlight and above other early stage biotechs who are trying to come up with a solution as well. There would be a substantial increase in the company’s value and it would absolutely be able to attract major attention from large pharmaceutical companies. It would give a much needed viable option for pancreatic cancer treatment.
The market size for pancreatic cancer is huge. Looking only at major developed countries, the market size should reach close to $3 billion within the next 5 years. If we look at the addressable market that in the United States only is equally impressive, which PMCB should easily be able to attain. A typical drug price for this disease is roughly between $50k and $75k per year. There are about 43,000 patients diagnosed with pancreatic cancer a year. Assuming that 60% of the patient pool would switch to PMCBs drug, the market size in the USA could be estimated at $1.25 billion to $1.8 billion. Given the market valuation is only $51 million, a successful positive trail will send shares flying through the stratosphere.
http://microcapspot.com/exciting-story-pharmacyte-biotech-inc-otcmktspmcb-continues/1061/
I think it is sinking in that last week's news was huge! IND coming and then trials. Eagerly awaiting the next news...
I always think about Dr. Hoff's involvement here. Just follow him and his interest in Cell-in-a-Box. I think he is also key in getting us this far. His passion for his patients gives me even greater confidence that we "on the cusp of the sun coming up."
He contacted us over 2 years ago and he and his team just made improvements to our trial design. They are
primary drivers to our success. We know he was on the Cancer Advisory Board of the FDA during Bush's admin...
Lots to feel good about here.
Good weekend to all!
Chamow will include a report with the IND on the facility's compliance. If IND approved, facility is cGMP. Therefore, I think the IND will come first and Pete is right on... We needed Thailand to approve the facility before anything else could happen. Their approval is the license to sell. Now we need the product approved and that approval will hinge on GMP compliance. Chamow should be reporting on that compliance...
"The facility is built according to the pre-approved floor plan and is now deemed suitable for the manufacture of pharmaceutical products.”
Personally, I am glad the flippers aren't getting any satisfaction on the recent updates... It can stay here until a buyout, imo...
I agree. This milestone is just as important as cGMP... With this behind us, we are ready to take off now..
GO PMCB LONGS!
Well, it's not really good news that diabetes cases have quadrupled for sure. However, it is good to note that there is a treatment in the pipeline that may cure the disease... Cell-in-a-Box (R) And Melligen Cells...
Wish all those involved in getting this treatment to patients the best...
It is a day of good news. May want to check out Austrianova's website... They appear to be making significant progress on the facility. Like them on FB too for updates. Feeling good about the progress I am seeing with the facility... And love the new clinical trial design.
GLTU
http://www.austrianova.com
Another good point...
You were absolutely on target, mind...
"I don't think most people are aware that our change in trial design also led to a change in GMP requirements at Austrianova's facility. When we changed our clinical trial design to meet what our 'world-renowned' oncologists felt was a therapy that can address a critical unmet medical need for pancreatic cancer patients, we moved the trial and trial sites predominantly to the U.S. so that Translational Drug Development (TD2) could head up the trial and do so under the watchful eyes of the FDA and EMA. Of course, this meant that Austrianova would now have to complete a great deal more documentation and processes than required by the TGA to comply with the GMP requirements of these two new regulatory agencies."
I had never considered that...
So sorry for your loss. PC is often not even detected until it's in later stages of the disease. There needs to be improvements in diagnosis as well...
GLTU
Details of the trial matter very much to me as well as GMP.
Seriously. This was a good solid PR for shareholders, those shareholders that are interested in seeing CiaB to the end point of improving the lives of those with PC.
Trial design is strong and the hospitals are certainly noteworthy. Just lets us know that things are moving along nicely.
I appreciate these updates...